BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIAMONDBACK CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 11619054 · Received April 6, 2021

    Report

    Report Number
    3004742232-2021-00113
    Event Type
    Death
    Date Received
    April 6, 2021
    Date of Event
    March 9, 2021
    Report Date
    April 6, 2021
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    UDI-DI
    10850000491356
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS CONCLUSION: THE DEVICE WAS RECEIVED AT CSI FOR ANALYSIS WITHOUT THE GUIDE WIRE. VISUAL EXAMINATION DID NOT REVEAL ANY DAMAGE. ADHERED BIOLOGICAL MATERIAL WAS OBSERVED ON THE DRIVESHAFT. EXAMINATION IN THE AREA OF THE ADHERED MATERIAL DID NOT REVEAL ANY DAMAGE THAT WOULD HAVE CONTRIBUTED TO THE ACCUMULATION. THE MORPHOLOGY AND EXACT ROOT CAUSE OF THE ACCUMULATION IS UNKNOWN. IT IS POSSIBLE THAT THE MATERIAL ACCUMULATION MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT; HOWEVER, THIS COULD NOT BE CONFIRMED. THE DEVICE DATA LOG WAS INTERROGATED AND SHOWED SEVERAL STALL EVENTS, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THE EXACT CAUSE OF THE STALL COULD NOT BE DETERMINED. THE OAD OPERATED AS INTENDED DURING FUNCTIONAL TESTING. AT THE CONCLUSION OF THE COMPLAINT ANALYSIS INVESTIGATION, THE REPORTED PERFORATION AND PATIENT DEATH COULD NOT BE CONFIRMED THROUGH ANALYSIS. THE REPORT THAT THE OAD BECAME STUCK ON THE WIRE ALSO COULD NOT BE CONFIRMED THROUGH ANALYSIS AS THE GUIDE WIRE WAS NOT RETURNED WITH THE OAD, AND A TEST WIRE PASSED THROUGH THE OAD WITHOUT RESISTANCE. THE DEVICE HISTORY RECORD FOR THIS OAD LOT NUMBER HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE MET MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS. CSI ID: (B)(4).

    Description of Event or Problem · 1

    A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) VIA RIGHT RADIAL ACCESS. TORTUOSITY WAS MODERATE, AND GLIDEASSIST WAS USED TO POSITION THE DEVICE DISTAL TO THE LESION FOR DISTAL TO PROXIMAL TREATMENT. ANGIOGRAPHY TAKEN AFTER THE FIRST TREATMENT SHOWED NO ISSUES, AND TWO MORE TREATMENT PASSES WERE PERFORMED WITHOUT ISSUE. THE OAD THEN BECAME STUCK ON THE GUIDE WIRE. GLIDEASSIST WAS ACTIVATED, BUT THE OAD STALLED. AN UNSUCCESSFUL ATTEMPT WAS MADE TO PLACE A SECOND WIRE PAST THE OAD CROWN TO HOLD WIRE POSITION; THE OAD AND WIRE WERE REMOVED TOGETHER. ANGIOGRAPHY THEN SHOWED EXTRAVASATION. THE LAD COULD NOT BE REWIRED. THE PATIENT COMPLAINED OF CHEST PAIN, AND EKG CHANGES OCCURRED. ACLS MEDICATIONS WERE ADMINISTERED, AND ET AND VENTILATOR SUPPORT WERE REQUIRED. A PERICARDIOCENTESIS WAS PERFORMED, AND AN IMPELLA WAS PLACED. THE PATIENT WAS SENT FOR CABG. THE PHYSICIAN STATED THAT THE COMPLICATED NATURE OF THE LESION, TORTUOSITY, AND NO OTHER TREATMENT OPTIONS BESIDES OA AND CABG COULD HAVE CONTRIBUTED TO THE COMPLICATIONS. THE PATIENT'S EJECTION FRACTION WAS GOOD FOLLOWING CABG. HOWEVER, THE PATIENT EXPIRED LATER THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515674 DIAMONDBACK CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 350186-1 10850000491356

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death